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Clinical Trials/NCT03465046
NCT03465046
Completed
Not Applicable

Modified Constraint Induced Movement Therapy and Bimanual Intensive Therapy in Children With Hemiplegia. Comparative Study

University of Salamanca1 site in 1 country41 target enrollmentOctober 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infantile Hemiplegia
Sponsor
University of Salamanca
Enrollment
41
Locations
1
Primary Endpoint
bimanual functional performance, "change" is being assessed
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This is a comparative study where two protocols of intensive therapies will be applied to study the improvements in the functional performance of the affected upper limb of children with hemiparesis and check whether to increase their quality of life.

Detailed Description

the intervention protocols combine different doses of intensive therapy, being 80 hours of modified constraint induced movement therapy followed by 20 hours for protocol 1 and protocol 2 would be the application of protocol 1 inverted, with this, the investigators want to compare how both protocols interfere in the function of the affected upper limb of children with different levels of bimanual functional performance.

Registry
clinicaltrials.gov
Start Date
October 15, 2018
End Date
January 30, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rocío Palomo Carrión

physiotherapist

University of Salamanca

Eligibility Criteria

Inclusion Criteria

  • Children diagnosed with Unilateral Infantile Cerebral Palsy, Congenital Infantile Hemiparesis.
  • Ages between 5 to 10 years.
  • Levels of I-III within the , manual ability classification system, MACS.
  • Levels of I-III within the gross motor function classification system, GMFCS

Exclusion Criteria

  • Diseases not associated with infantile hemiparesis.
  • Low cognitive level to understand the execution of activities.
  • Surgeries of the upper extremity during the 6 months prior to the intervention.
  • Structured contractures in the affected upper extremity that cause functional impotence.
  • Botulinum toxin two months prior to the intervention and application of it during the treatment.
  • Epilepsy not controlled pharmacologically

Outcomes

Primary Outcomes

bimanual functional performance, "change" is being assessed

Time Frame: 4 assessments will be carried out in the research in 10 weeks

use of the affected upper extremity of spontaneous character during bimanual activities. It is used the AHA assessment to measure it.

Secondary Outcomes

  • quality of life ,"change" is being assessed(4 assessments will be carried out in the research in 10 weeks)

Study Sites (1)

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